A Single-arm, Multicenter Study to Evaluate the Safety and Efficacy of Candonilimab (AK104) Combined With Regorafenib for Third-line Treatment of MSS Colorectal Liver Metastasis

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Candonilimab (AK104) combined with Regorafenib for treating patients with microsatellite stable (MSS) colorectal cancer that has spread to the liver. This study focuses on patients who have not responded to previous second-line treatments. It will also explore biomarkers to better understand how well the treatment works. Participants will receive Candonilimab (AK104), a humanized antibody given by intravenous infusion every two weeks at a dose of 6 mg/kg, along with Regorafenib, an oral drug taken daily at 80 mg for three weeks followed by one week off in each four-week cycle. This is a single-arm, open-label, multicenter study where all participants receive the combination treatment. During the study, participants will have regular assessments including scans to measure tumor response, laboratory tests to monitor organ function, and evaluations for side effects. The main outcome measured is the objective response rate at six months. Other outcomes include disease control, duration of response, progression-free survival at six months, overall survival up to two years, and incidence of adverse events. Participants' involvement will last through treatment and follow-up periods as specified in the protocol.

Cadonilimab Combined With Regorafenib as A Third-line Treatment in Patients With MSS CRLM